Ireland
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Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Limb Lymphedema

NCT07622615 · tracked via the Priya Life Science France tracker
Sponsor
Jean-Paul Belgrado
Phase
Not applicable
Started
2026-07-01
Last updated
2026-06-03

Condition(s) studied

Lymphedema Lower Extremity

Investigational drug(s) / intervention(s)

Control group: Traditional multicomponent bandagesDDS group: Dynamic compression device (DDS)

Control group: Traditional multicomponent bandages: In the control group, patients will wear traditional multicomponent bandages as a compression therapy modality 24/24 during the first 5 days of intensive treatment

DDS group: Dynamic compression device (DDS): Patients in the DDS group will wera the inverventional dynamic compression device as a compression modality 24/24 during the first five days of inpatient intensive treatment.

Study summary

The goal of this study is to compare the efficacy of a dynamic compression device (DDS) with traditional multicomponent bandages (TMCB) in terms of excess volume reduction in lower limb lymphoedema during the first 5 days of intensive treatment.

Participants in both groups will undergo the standard decongestive treatment protocol of the trial site. The only difference between both groups will be the modality of the compression therapy:

* the intervention (DDS) group will wear the compression 24/24 during the first 5 days of intensive treatment
* the control group will wear TMCB 24/24 during the first 5 days of intensive treatment (i.e. the standard treatment)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Men and women * Unilateral lower limb lymphoedema of stage II or III according to the criteria defined by the International Society of Lymphology * Relative volume difference between affected and healthy leg ≥ 10% * Patients requiring intensive decongestive treatment in a hospital setting * Patients who have given their informed consent freely and signed it prior to any intervention in the study. * Patients with a morphology compatible with the perimetric coverage of the device (calf and thigh). * Patients able to use the device * Patients enrolled in a social security plan or covered by similar health insurance. Exclusion Criteria: * Patients with suspended lymphoedema of the thigh (unaffected calf and foot) * Patients with lipedema * Patients with bilateral lower limb lymphoedema * Patients with a lymphoedema associated with active cancer requiring acute chemotherapy, or oncologic relapses, or treatment in progress * Patients with contraindications for compression on the lower limbs such as stent/arterial graft in the area under compression * Peripheral artery disease ABI ≤ 0.6 * Advanced diabetic microangiopathy * Deep/Superficial active or recent venous thrombosis, phlegmasia ceruela dolens (painful blue inflammation), septic/acute thrombophlebitis of the limb (in the last 6 months), active venous leg ulcers * A condition where increased venous or lymphatic return is undesirable * Neurological disease (including neurogenic diabetic foot, severe peripheral neuropathy of the limb) * Pulmonary embolism (last 6 months) * Pulmonary edema * Cardiac insufficiency (compensated or decompensated) * Implantable stimulation devices such as pacemaker * Chronic kidney disease with acute renal failure * Epilepsy * Poorly controlled asthma * Open skin lesions or skin and subcutaneous infection (cellulitis, erysipelas, lymphangitis, etc.) * Skin atrophy of the limb * Bullous dermatoses * Presence of subcutaneous osteosynthesis material with an external component lying subdermally at the level of the treated lower limb * Hyperalgesia of the foot, knee or hip * Patients with a known allergy to the components used in the device * Patients with psychiatric, psychological, or neurological disorders * Patients with impaired cognitive or motor skills and dependent individuals * Patients participating in another clinical trial * Pregnant or breastfeeding women * Vulnerable patients, adults being the object of a legal protective measure or unable to express their consent * Patients unable to submit to the constraints of the protocol

Primary outcome measure(s)

  • Relative excess limb volume (%) during intensive treatment — 5 days
    The primary outcome is the relative excess limb volume reduction (percent change) during the first 5 days of intensive treatment. Relative excess volume (%) will be calculated from serial limb volume measurements obtained once or twice daily, according to the number of bandage applications in each center's standard protocol, and expressed as the percentage reduction from baseline. This percentage change will be compared between the two treatment groups, with higher percentage reduction indicating a better decongestive outcome.

Trial sites (3)

FacilityCityRegionStatus
CHU Montpellier - Saint Eloi Montpellier France
CHU Toulouse - Rangueil Toulouse France
Lympho-Opt Fachklinik fur Lymphologie Pommelsbrunn Bavaria
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07622615 on ClinicalTrials.gov ↗ ← All trials in France